MAUDE Adverse Event Report: DEPUY SPINE INC VIPER 2 SYSTEM DRIVER, CANNULATED T20; DRIVER, PROSTHESIS

Model Number	286725020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.A review of the receiving inspection (ri) for viper2 t20 hexlobe driver shaf was conducted identifying that lot number x0710 was released in a single batch.Batch 1: lot qty of (b)(4) units were released on 16 aug 2010 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2021, during a posterior spinal fusion surgery the viper2 t20 hexlobe driver shaft was being used in a percutaneous screw case.The driver tip was broken off and retrieved by the surgeon.Fragments were generated and easily removed.There was no surgical delay.There were no patient consequences.The procedure was successfully completed.Concomitant device: unknown screw (part # unknown, lot # unknown, quantity unknown).This report is for one (1) viper 2 system driver, cannulated t20.This is report 1 of 1 for (b)(4).

• Brand Name: VIPER 2 SYSTEM DRIVER, CANNULATED T20
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11969784
• Report Number: 1526439-2021-01200
• Device Sequence Number: 17234947
• Product Code: HWR
• UDI-Device Identifier: 10705034214290
• UDI-Public: 10705034214290
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 286725020
• Device Catalogue Number: 286725020
• Device Lot Number: X0710
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1